RESEARCH OPPORTUNITIES IN TISSUE ENGINEERING RELEASE DATE: December 30, 2002 RFA: EB-03-010 National Institute of Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib1.nih.gov/) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov) LETTER OF INENT RECEIPT DATE: February 14, 2003 APPLICATION RECEIPT DATE: March 14, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The National Institute of Biomedical Imaging and Bioengineering (NIBIB) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) issue this Request for Applications (RFA) to address key research challenges in the field of tissue engineering. The full promise of tissue engineering as a means to develop functional tissue or organ substitutes in vitro for implantation in vivo, or to remodel and regenerate tissue in vivo for the purpose of repairing, replacing, maintaining, or enhancing organ function, is only beginning to be realized. Tissue engineering also offers a potential source of human tissues for use as biosensors or for the development of drugs including screening for novel drug candidates, identifying novel genes as drug targets or therapeutic agents, and testing for drug toxicity. As an emerging multidisciplinary field in which ideas, concepts, and techniques are developing at an exceedingly rapid pace, there is significant interest and demand for government agencies to provide additional resources in this and related areas for fostering the basic and applied science needed for this field to mature and important breakthroughs to transition from basic and pre-clinical research to clinical studies. The overall goal of this solicitation is to provide resources to address the issues that must be overcome in order to continue to move this field forward rapidly. It is structured to provide an opportunity where clinicians, engineers, and scientists from a variety of disciplines can establish research collaborations that will hasten the development of tissue engineering. RESEARCH OBJECTIVES Tissue engineering is a rapidly growing area that seeks to create, repair and/or replace tissues and organs by using combinations of cells, biomaterials, and/or biologically active molecules. It is an interdisciplinary field that integrates aspects of engineering, and other quantitative sciences, with biology and medicine. Research and technology development in tissue engineering promises to revolutionize current methods of health care treatment and significantly improve the quality of life for millions of patients. As one indication of the scope of the problem that tissue engineering addresses, worldwide organ replacement therapies utilizing standard organo-metallic devices consume 8 percent of medical spending, or approximately $350 billion per year. Organ transplantation is another option for replacing damaged or diseased tissue, but one that is severely limited by donor availability. Tissue-engineered products hold the promise for true functional replacement at affordable cost. However, despite early successes, few functional tissue engineered products are currently available for clinical use. As described in the January 2002 World Technology Evaluation Center (WTEC) report, "Tissue Engineering Research", it is clear that critical advances in engineering and design are needed and key regulatory issues must be addressed if the promises of this field are to be fulfilled. The report is based on findings of the WTEC study supported by member agencies of the Multi-Agency Tissue Engineering Science (MATES) Working Group http://www.tissueengineering.gov/. These include the National Institutes of Health (NIH), National Science Foundation (NSF), National Institute of Standards and Technology (NIST), National Aeronautics and Space Administration (NASA), Defense Advanced Research Projects Agency (DARPA), and the Food and Drug Administration (FDA). The research areas covered and described in this solicitation represent a collective effort of the MATES Working Group. In addition, as discussed in several other recent forums such as the 2001 NIH/BECON sponsored meeting on "Reparative Medicine: Growing Tissues and Organs" http://www.becon.nih.gov/becon_symposia.htm and the 2001 NIST sponsored workshop on "Standards for Biomedical Materials and Devices," there are a number of areas in tissue engineering requiring additional research. These include: improved methods for the identification and characterization of cells; development of novel biomaterials; new approaches to the design and delivery of three dimensional constructs; and development of enabling technologies and methods to ensure the safety and quality assurance of engineered tissues as well as methods for the stable storage of these products prior to clinical use. As the field evolves from initial proof-of-principle demonstrations of feasibility to the development of products intended for widespread clinical use, the NIBIB and the NIDDK are in a unique position to foster developments in this area by providing resources to ensure that these obstacles are successfully overcome and that these revolutionary products move from the research bench to the clinic. Strengthening research programs of relevance to tissue engineering and eventual clinical utilization of products developed by this field are important areas of emphasis for the NIBIB and NIDDK. Areas in which such scientific opportunities exist include, but are not limited to: 1. Identification/Characterization of Cells and Development of Novel Biomaterials The identification of an optimal cell source for a particular tissue engineering application will depend on rigorous characterization with regards to plasticity, propagation, and control of differentiation both in vitro and in vivo. To guide the organization, growth, and differentiation of cells in tissue engineered constructs, a variety of biomaterials are needed to provide mechanical support as well as physical, chemical, and mechanical cues in forming functional tissues. These materials and their degradation products must be non-toxic and non-immunogenic, as well as possess other properties specific for a given tissue construct and the site of implantation. It is clear that the continued development of this field will depend upon identification and characterization of additional sources of cells as well as the development of new biomaterials and increased understanding of their interactions with cells. Specific areas of interest include but are not limited to: o Isolation of stem and progenitor cells and methods to promote targeted stimulation of proliferation and controlled differentiation, including evaluation of signaling pathways in differentiation and dedifferentiation. o Development of novel scaffolds and delivery vehicles that combine bioactive molecules, such as growth factors or DNA, to coordinate the temporal and spatial distribution of biomolecules in relation to the desired cellular response. o Incorporation of new biomaterials and polymer classes of interest to tissue engineering into material libraries as reference standards or tools for validation purposes. o In addition to the above the NIDDK is specifically interested in engineering tissues to replace the function of pancreatic beta cells, liver, kidney and bladder. 2. Engineering Design and Functional Assessment of Constructs: Advances are needed in the application of rational engineering design principles to tissue engineered constructs and the design must span multiple hierarchical scales, from the macroscopic level, directed at satisfying the clinical requirements of the product, to the microscopic level, directed at satisfying the cell and molecular requirements for long-term functional success. Determining the fate and function of implanted constructs is also of critical importance. Specific areas of interest include but are not limited to: o Novel approaches to materials processing to create scaffolds, which allow composition variation to accommodate divergence in evolving tissue structures. o Development of strategies to promote vascularization and/or innervation within engineered tissues or in vivo. o Model systems to understand physical, chemical and biomechanical aspects of cell signaling o Consideration of multiple design and delivery approaches for in vitro tissue preparations and in situ tissue regeneration, such as methods to direct self assembly/maturation of bioscaffolds leading to in situ generation of constructs o Achievement of immunological tolerance for engineered constructs o Increased understanding of the basic principles governing tissue formation, function, and failure, including the assembly of multiple cell types and biomaterials into multi-dimensional structures that mimic the architecture and/or function of native tissue. o Methodologies, such as various imaging modalities, to track the fate and allow the assessment of implanted engineered constructs in a non-invasive or minimally invasive manner. 3. Enabling Technologies If the benefits of tissue engineering are to be realized, the field must deliver products that can be commercialized. Therefore, a wide range of enabling technologies, such as techniques for use in growing tissues/organs on a commercially relevant scale; new, relevant, pre- clinical models; methods to establish biosafety, quality assurance and performance; strategies for preserving living-cell products with off- the-shelf availability and determining the fate of the implanted constructs will be required. Specific areas of interest include but are not limited to: o New sensitive and rapid test methods to address biosafety, function and stability of the final engineered construct. o Development of appropriate in vitro and in vivo pre-clinical models to address biocompatibility, toxicity, immunogenicity and inflammatory responses. o Development of relevant in vitro tests to predict the in vivo performance of tissue engineered medical products, both for product development and quality control in manufacturing. o Cost effective approaches for the production of tissues and organs, that can meet regulatory requirements for good manufacturing practices (GMP). o Techniques and technologies for preserving both cells and engineered tissues to permit the stable storage of these products prior to clinical utilization. o Three-dimensional tissue production including development of bioreactor and organ support systems. MECHANISM OF SUPPORT This RFA will use the NIH research grant award mechanism (R01) and the development/exploratory grant award mechanism (R21). As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation R01 applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is September 30, 2003. The R01 mechanism is recommended for applications that emphasize basic discovery or crosscutting research that addresses specific aspects of tissue engineering. Research periods associated with the R01 proposals are limited to five years with no cap on budget amount. The R21 Exploratory/Developmental Award supports exploratory or developmental research aimed at proof-of-principle for high-risk projects where no or very little preliminary data is available. An R21 application can be for up to two years with a maximum budget request of $275,000 direct costs for the 2-year period and a maximum page limit of 15 pages. R21 applications are not renewable. Investigators are encouraged to use data generated from the R21 application to apply for further funding through the R01 mechanism (or other appropriate mechanisms). This RFA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting formats (see https://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs (including total costs of consortium arrangements) in each year of $250,000 or less, use the modular format. Otherwise follow the instructions for non-modular research grant applications. FUNDS AVAILABLE The NIBIB intends to commit a total of approximately $8,000,000, and the NIDDK intends to commit a total of approximately $350,000 in FY 2003 to fund 20 to 30 new and/or competitive continuation grants in response to this RFA. An applicant may request a project period of up to 5 years for an R01 and a project period of up to 2 years for an R21. Budgets for direct costs of up to $275,000 for the 2-year period will be accepted for an R21. There is no budget limitation for R01 applications. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NIBIB and the NIDDK provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS General Clinical Research Centers: Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator should be included with the application. Grantee Meetings: Principal Investigators will be required to attend an annual meeting in the Bethesda, MD region organized by NIBIB. Investigators must include travel to this meeting as part of the budget request and state a willingness to participate in this meeting. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues: o Direct your questions about scientific/research issues to: Christine A. Kelley, Ph.D. Acting Director Division of Bioengineering National Institute of Biomedical Imaging and Bioengineering NIH/DHHS Suite 200 6707 Democracy Blvd. Bethesda, MD 20892-5469 Telephone: (301) 451-4778 Fax: (301) 480-4973 Email: kelleyc@mail.nih.gov Maren R. Laughlin, Ph.D. Director, Metabolism Program NIDDK NIH/DHHS 6707 Democracy Blvd, Rm. 6101, MSC 5460 Bethesda, MD 20892-5460 Telephone: (301) 594-8802 Fax: (301) 480-3503 Email: laughlinm@extra.niddk.nih.gov o Direct your questions about financial or grants management matters to: Ms. Nancy Curling Division of Extramural Activities National Institute of Biomedical Imaging and Bioengineering NIH/DHHS Suite 900 6707 Democracy Blvd. Bethesda, MD 20892 Telephone: (301) 451-4782 Fax: 301-480-4974 Email: curlingn@nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Meredith D. Temple, Ph.D. Health Scientist Administrator Division of Extramural Activities National Institute of Biomedical Imaging and Bioengineering NIH/DHHS Suite 200 6707 Democracy Blvd. Bethesda, MD 20892 Telephone: (301) 451-4792 Fax: (301) 480-4973 Email: templem@mail.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at https://grants.nih.gov/grants/funding/phs398/phs398.html includes step- by-step guidance for preparing modular grants. Additional information on modular grants is available at https://grants.nih.gov/grants/funding/modular/modular.htm. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and five signed, photocopies, in one package to: Center For Scientific Review National Institutes Of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. Please Note: As of November 27, 2001, all applications and other deliveries to the Center for Scientific Review must come via courier delivery or the USPS. Applications delivered by individuals to the Center for Scientific Review will no longer be accepted. For additional information, see the NIH Guide Notice https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIBIB. Incomplete applications will be returned to the applicant without further consideration. And, if the application is not responsive to the RFA, CSR staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the CSR in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a second level review by the appropriate National Advisory Council. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE: Does your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will be reviewed with respect to the following: o TEAM-APPROACH: The inclusion of researchers with divergent backgrounds, for example, the partnering of an engineer, a physiologist and/or a clinician. o R21 REVIEW CRITERIA: Since the R21 mechanism is intended to encourage exploratory/developmental research, proposals submitted as an R21 will also be reviewed based on their high risk/high impact potential and whether or not the proposal is significantly distinct from those traditionally submitted through the R01 mechanism. For example, R21 projects designed to produce incremental advances in knowledge will not be considered. o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: February 14, 2003 Application Receipt Date: March 14, 2003 Peer Review Date: May/June, 2003 Council Review: September, 2003 Earliest Anticipated Start Date: September 30, 2003 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. REQUIRED FEDERAL CITATIONS INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub- populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH- defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at https://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at https://grants.nih.gov/grants/stem_cells.htm and at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.286 & 93.287 (NIBIB) and 93.847, 93.848 & 93.849 (NIDDK) and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at https://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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